Mass spectrometers

Mass spectrometers for physical or chemical analysis

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9027 81 00 (Mass spectrometers) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW) when the instrument is classified as a listed medical device. Extended Producer Responsibility (EPR) authorisation from the Central Pollution Control Board (CPCB) under Schedule I of the E-Waste (Management) Rules, 2022 applies concurrently, and import of used or refurbished high-value medical equipment is additionally restricted per the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.

What this is

HSN code

9027 81 00

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020 (Medical Devices Rules, 2017)

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Import permit from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Verify whether the mass spectrometer is listed under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. If listed, obtain CDSCO registration and ensure all conditions stated in G.S.R. 102(E) — including importer and foreign-manufacturer registration — are met before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
2
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of analysers and accessories, as required under Schedule I of the E-Waste (Management) Rules, 2022. EPR authorisation is not required for micro-enterprises as defined in the MSME Development Act, 2006; all other importers must upload the EPR authorisation in e-Sanchit before out-of-charge.
G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022
3
If importing used or refurbished high-end, high-value medical equipment — other than critical care medical equipment — confirm compliance with the conditions specified in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023, under which such imports are restricted.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is treating CDSCO registration and EPR authorisation as mutually exclusive obligations rather than concurrent ones. An importer who secures CDSCO registration for a listed medical-device mass spectrometer but arrives at the bill of entry without CPCB EPR authorisation faces detention and demurrage — the EPR obligation applies to all importers of electronic analysers and accessories regardless of device-classification status, with the sole carve-out for MSME-Act micro-enterprises.

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Frequently asked

Does HSN 9027 81 00 require BIS certification?

No, mass spectrometers are not within the BIS Quality Control Order regime. Import is governed by CDSCO registration under G.S.R. 102(E) dated 11-02-2020 where the instrument is a listed medical device, with a concurrent EPR authorisation requirement from the Central Pollution Control Board under the E-Waste (Management) Rules, 2022.

Does the EPR authorisation requirement apply if the importing entity is a small business?

No. EPR authorisation under G.S.R. 801(E) and Schedule I of the E-Waste (Management) Rules, 2022 does not apply to micro-enterprises as defined in the MSME Development Act, 2006; all other importers must hold a current EPR authorisation at the time of import.

Are used or refurbished mass spectrometers freely importable under this HSN?

No. Import of high-end, high-value used or refurbished medical equipment — other than critical care equipment — is restricted and subject to conditions specified in the Ministry of Environment, Forest and Climate Change Office Memorandum dated 15-12-2023; a separate CDSCO medical-device classification assessment is also required where the instrument is a listed device.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / CPCB / MOHFW / MEFCC / Indian Customs CUSDATA.